Kinematic, Kinetic, and Metabolic Comparison of Bilateral Transfemoral Ambulation With Passive Versus Powered Prosthetic Devices

Amputation Clinical Trial

Official title:

Kinematic, Kinetic, and Metabolic Comparison of Bilateral Transfemoral Ambulation With Passive Versus Powered Prosthetic Devices

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02366702
• Other study ID #: 01329
• Status: Active, not recruiting
• Start date: February 2015
• Est. completion date: February 2020

Study information

• Verified date: April 2019
• Source: Southern California Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this descriptive and exploratory pilot study is to investigate: (1) sagittal plane hip kinematics and kinetics and (2) metabolic consumption/cost, for bilateral transfemoral walking with passive prostheses versus powered prostheses. The pilot study will collect data from three subjects with bilateral transfemoral amputations. Differences in kinetics, kinematics, and oxygen consumption/cost when comparing passive and powered components may indicate benefits for clinical application of powered devices for persons with lower limb amputation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3
• Est. completion date: February 2020
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Male or female

• All causes of limb amputation: congenital, trauma, vascular, limb salvage, infection.

• All transfemoral residual limb lengths: joint disarticulation, long, medium, short, very short.

• Subjects currently walk with entirely passive type prostheses daily.

• Subjects walk without assistive devices OR with single point cane.

• High-activity level walkers

Exclusion Criteria:

• Ages < 18 or > 45 years

• Medical comorbidities or existing conditions that may impede the subjects ability to complete the protocol excluding the amputations.

• Current medications or pharmaceutical interventions that may impede the subjects ability to complete the protocol.

• Any powered prosthetic component or prosthesis, including but not exclusive to: Ossur Proprio Foot, BiOM or BiOM T2 System Foot, Ossur Power Knee, Ossur Symbionic Leg.

• Subjects requiring a walker, crutches, quad cane, or other assistive devices excluding a single point cane.

• Low-activity level walkers

Related Conditions & MeSH terms

• Amputation
• Artificial Limbs
• Energy Expenditure
• Kinetics

Intervention

Device:
• Lower Limb Powered Knee-Ankle Prosthesis

Locations

Country	Name	City	State
United States	VA Long Beach Healthcare System	Long Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
Southern California Institute for Research and Education	Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (52)

A. Cunha, E. Caetano, P. Ribeiro, G. Müller (eds.) Proceedings of the 9th International Conference on Structural Dynamics, EURODYN 2014. Porto, Portugal, 30 June - 2 July 2014

Adams PF, Hendershot GE, Marano MA; Centers for Disease Control and Prevention/National Center for Health Statistics. Current estimates from the National Health Interview Survey, 1996. Vital Health Stat 10. 1999 Oct;(200):1-203. — View Citation

Alimusaj M, Fradet L, Braatz F, Gerner HJ, Wolf SI. Kinematics and kinetics with an adaptive ankle foot system during stair ambulation of transtibial amputees. Gait Posture. 2009 Oct;30(3):356-63. doi: 10.1016/j.gaitpost.2009.06.009. Epub 2009 Jul 17. — View Citation

Ayyappa, E. (1997). Normal human locomotion, part 1: Basic concepts and terminology. JPO: Journal of Prosthetics and Orthotics, 9(1), 10-17

Ayyappa, E. (1997). Normal human locomotion, Part 2: Motion, ground-reaction force and muscle activity. JPO: Journal of Prosthetics and Orthotics, 9(2), 49-57

Barr AE, Siegel KL, Danoff JV, McGarvey CL 3rd, Tomasko A, Sable I, Stanhope SJ. Biomechanical comparison of the energy-storing capabilities of SACH and Carbon Copy II prosthetic feet during the stance phase of gait in a person with below-knee amputation. Phys Ther. 1992 May;72(5):344-54. — View Citation

Barth, D. G., Schumacher, L., & Thomas, S. S. (1992). Gait analysis and energy cost of below-knee amputees wearing six different prosthetic feet. JPO: Journal of Prosthetics and Orthotics, 4(2), 63-75

Biswas, D., Roy, S., Lenka, P. K., & Kumar, R. (2010). Energy Cost and Gait Efficiency of Below-Knee Amputee and Normal Subject with Similar Physical Parameters & Quality of Life: A Comparative Case Study. Online Journal of Health and Allied Sciences, 9(3)

Brockway JM. Derivation of formulae used to calculate energy expenditure in man. Hum Nutr Clin Nutr. 1987 Nov;41(6):463-71. — View Citation

Chin T, Sawamura S, Shiba R. Effect of physical fitness on prosthetic ambulation in elderly amputees. Am J Phys Med Rehabil. 2006 Dec;85(12):992-6. — View Citation

Cutti, A. G., Raggi, M., Garofalo, P., Giovanardi, A., Filippi, M. V., & Davalli, A. (2008). The effects of the 'Power Knee'prosthesis on amputees metabolic cost of walking and symmetry of gait—Preliminary results. Gait & Posture, 28, S38

Darter BJ, Wilken JM. Energetic consequences of using a prosthesis with adaptive ankle motion during slope walking in persons with a transtibial amputation. Prosthet Orthot Int. 2014 Feb;38(1):5-11. doi: 10.1177/0309364613481489. Epub 2013 Mar 22. — View Citation

Delussu AS, Brunelli S, Paradisi F, Iosa M, Pellegrini R, Zenardi D, Traballesi M. Assessment of the effects of carbon fiber and bionic foot during overground and treadmill walking in transtibial amputees. Gait Posture. 2013 Sep;38(4):876-82. doi: 10.1016/j.gaitpost.2013.04.009. Epub 2013 May 21. — View Citation

Dougherty PJ, McFarland LV, Smith DG, Reiber GE. Combat-incurred bilateral transfemoral limb loss: a comparison of the Vietnam War to the wars in Afghanistan and Iraq. J Trauma Acute Care Surg. 2012 Dec;73(6):1590-5. doi: 10.1097/TA.0b013e318265fe64. — View Citation

Feinglass J, Brown JL, LoSasso A, Sohn MW, Manheim LM, Shah SJ, Pearce WH. Rates of lower-extremity amputation and arterial reconstruction in the United States, 1979 to 1996. Am J Public Health. 1999 Aug;89(8):1222-7. — View Citation

Ferris AE, Aldridge JM, Rábago CA, Wilken JM. Evaluation of a powered ankle-foot prosthetic system during walking. Arch Phys Med Rehabil. 2012 Nov;93(11):1911-8. doi: 10.1016/j.apmr.2012.06.009. Epub 2012 Jun 22. — View Citation

Fradet L, Alimusaj M, Braatz F, Wolf SI. Biomechanical analysis of ramp ambulation of transtibial amputees with an adaptive ankle foot system. Gait Posture. 2010 Jun;32(2):191-8. doi: 10.1016/j.gaitpost.2010.04.011. Epub 2010 May 8. — View Citation

Frossard L, Cheze L, Dumas R. Dynamic input to determine hip joint moments, power and work on the prosthetic limb of transfemoral amputees: ground reaction vs knee reaction. Prosthet Orthot Int. 2011 Jun;35(2):140-9. doi: 10.1177/0309364611409002. — View Citation

Gao F, Zhang F, Huang H. Investigation of sit-to-stand and stand-to-sit in an above knee amputee. Conf Proc IEEE Eng Med Biol Soc. 2011;2011:7340-3. doi: 10.1109/IEMBS.2011.6091712. — View Citation

Herr HM, Grabowski AM. Bionic ankle-foot prosthesis normalizes walking gait for persons with leg amputation. Proc Biol Sci. 2012 Feb 7;279(1728):457-64. doi: 10.1098/rspb.2011.1194. Epub 2011 Jul 13. — View Citation

Highsmith, M. J., Kahle, J. T., Carey, S. L., Lura, D. J., Dubey, R. V., & Quillen, W. S. (2010). Kinetic differences using a power knee and C-Leg while sitting down and standing up: a case report. JPO: Journal of Prosthetics and Orthotics, 22(4), 237-243

Hitt, J. K., Sugar, T. G., Holgate, M., & Bellman, R. (2010). An active foot-ankle prosthesis with biomechanical energy regeneration. Journal of medical devices,4(1), 011003

Hoffman MD, Sheldahl LM, Buley KJ, Sandford PR. Physiological comparison of walking among bilateral above-knee amputee and able-bodied subjects, and a model to account for the differences in metabolic cost. Arch Phys Med Rehabil. 1997 Apr;78(4):385-92. — View Citation

Hughes J, Jacobs N. Normal human locomotion. Prosthet Orthot Int. 1979 Apr;3(1):4-12. — View Citation

Kadaba MP, Ramakrishnan HK, Wootten ME. Measurement of lower extremity kinematics during level walking. J Orthop Res. 1990 May;8(3):383-92. — View Citation

Kurdibaylo SF. Obesity and metabolic disorders in adults with lower limb amputation. J Rehabil Res Dev. 1996 Oct;33(4):387-94. — View Citation

Lawson BE, Huff A, Goldfarb M. A preliminary investigation of powered prostheses for improved walking biomechanics in bilateral transfemoral amputees. Conf Proc IEEE Eng Med Biol Soc. 2012;2012:4164-7. doi: 10.1109/EMBC.2012.6346884. — View Citation

Lawson BE, Ruhe B, Shultz A, Goldfarb M. A powered prosthetic intervention for bilateral transfemoral amputees. IEEE Trans Biomed Eng. 2015 Apr;62(4):1042-50. doi: 10.1109/TBME.2014.2334616. Epub 2014 Jul 2. — View Citation

Martinez-Villalpando EC, Herr H. Agonist-antagonist active knee prosthesis: a preliminary study in level-ground walking. J Rehabil Res Dev. 2009;46(3):361-73. — View Citation

McNealy LL, Gard SA. Effect of prosthetic ankle units on the gait of persons with bilateral trans-femoral amputations. Prosthet Orthot Int. 2008 Mar;32(1):111-26. doi: 10.1080/02699200701847244. — View Citation

Miller WC, Deathe AB, Speechley M. Lower extremity prosthetic mobility: a comparison of 3 self-report scales. Arch Phys Med Rehabil. 2001 Oct;82(10):1432-40. — View Citation

Mohanty RK, Lenka P, Equebal A, Kumar R. Comparison of energy cost in transtibial amputees using "prosthesis" and "crutches without prosthesis" for walking activities. Ann Phys Rehabil Med. 2012 May;55(4):252-62. doi: 10.1016/j.rehab.2012.02.006. Epub 2012 Apr 10. English, French. — View Citation

Nolan L, Lees A. The functional demands on the intact limb during walking for active trans-femoral and trans-tibial amputees. Prosthet Orthot Int. 2000 Aug;24(2):117-25. — View Citation

Perry, J., Burnfield, J. M., & Cabico, L. M. (2010). Gait analysis: Normal and pathological function. Thorofare, NJ: SLACK

Quintero HA, Farris RJ, Ha K, Goldfarb M. Preliminary assessment of the efficacy of supplementing knee extension capability in a lower limb exoskeleton with FES. Conf Proc IEEE Eng Med Biol Soc. 2012;2012:3360-3. doi: 10.1109/EMBC.2012.6346685. — View Citation

Schmalz T, Blumentritt S, Jarasch R. Energy expenditure and biomechanical characteristics of lower limb amputee gait: the influence of prosthetic alignment and different prosthetic components. Gait Posture. 2002 Dec;16(3):255-63. — View Citation

Schmalz T, Blumentritt S, Marx B. Biomechanical analysis of stair ambulation in lower limb amputees. Gait Posture. 2007 Feb;25(2):267-78. Epub 2006 May 24. — View Citation

Schneider K, Hart T, Zernicke RF, Setoguchi Y, Oppenheim W. Dynamics of below-knee child amputee gait: SACH foot versus Flex foot. J Biomech. 1993 Oct;26(10):1191-204. — View Citation

Simon AM, Ingraham KA, Fey NP, Finucane SB, Lipschutz RD, Young AJ, Hargrove LJ. Configuring a powered knee and ankle prosthesis for transfemoral amputees within five specific ambulation modes. PLoS One. 2014 Jun 10;9(6):e99387. doi: 10.1371/journal.pone.0099387. eCollection 2014. — View Citation

Snyder RD, Powers CM, Fontaine C, Perry J. The effect of five prosthetic feet on the gait and loading of the sound limb in dysvascular below-knee amputees. J Rehabil Res Dev. 1995 Nov;32(4):309-15. — View Citation

Su PF, Gard SA, Lipschutz RD, Kuiken TA. Gait characteristics of persons with bilateral transtibial amputations. J Rehabil Res Dev. 2007;44(4):491-501. — View Citation

Sup F, Varol HA, Mitchell J, Withrow TJ, Goldfarb M. Self-Contained Powered Knee and Ankle Prosthesis: Initial Evaluation on a Transfemoral Amputee. IEEE Int Conf Rehabil Robot. 2009 Jun 23;2009:638-644. — View Citation

Sup, F., Bohara, A., & Goldfarb, M. (2007, April). Design and control of a powered knee and ankle prosthesis. In Robotics and Automation, 2007 IEEE International Conference on (pp. 4134-4139). IEEE

Torburn L, Powers CM, Guiterrez R, Perry J. Energy expenditure during ambulation in dysvascular and traumatic below-knee amputees: a comparison of five prosthetic feet. J Rehabil Res Dev. 1995 May;32(2):111-9. — View Citation

Versluys R, Beyl P, Van Damme M, Desomer A, Van Ham R, Lefeber D. Prosthetic feet: state-of-the-art review and the importance of mimicking human ankle-foot biomechanics. Disabil Rehabil Assist Technol. 2009 Mar;4(2):65-75. doi: 10.1080/17483100802715092. Review. — View Citation

Vrieling AH, van Keeken HG, Schoppen T, Otten E, Halbertsma JP, Hof AL, Postema K. Uphill and downhill walking in unilateral lower limb amputees. Gait Posture. 2008 Aug;28(2):235-42. doi: 10.1016/j.gaitpost.2007.12.006. Epub 2008 Feb 1. — View Citation

Waters RL, Perry J, Antonelli D, Hislop H. Energy cost of walking of amputees: the influence of level of amputation. J Bone Joint Surg Am. 1976 Jan;58(1):42-6. — View Citation

Wolf EJ, Everding VQ, Linberg AA, Czerniecki JM, Gambel JM. Comparison of the Power Knee and C-Leg during step-up and sit-to-stand tasks. Gait Posture. 2013 Jul;38(3):397-402. doi: 10.1016/j.gaitpost.2013.01.007. Epub 2013 Jan 30. — View Citation

Wolf SI, Alimusaj M, Fradet L, Siegel J, Braatz F. Pressure characteristics at the stump/socket interface in transtibial amputees using an adaptive prosthetic foot. Clin Biomech (Bristol, Avon). 2009 Dec;24(10):860-5. doi: 10.1016/j.clinbiomech.2009.08.007. Epub 2009 Sep 9. — View Citation

Wolf, E. J., & Pruziner, A. L. (2014). Use of a Powered Versus a Passive Prosthetic System for a Person with Bilateral Amputations during Level-Ground Walking. JPO: Journal of Prosthetics and Orthotics, 26(3), 166-170

Wu YJ, Chen SY, Lin MC, Lan C, Lai JS, Lien IN. Energy expenditure of wheeling and walking during prosthetic rehabilitation in a woman with bilateral transfemoral amputations. Arch Phys Med Rehabil. 2001 Feb;82(2):265-9. — View Citation

Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005. — View Citation

* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sagittal Plane Hip Moment		During the stance phase of the gait cycle after two weeks of training with powered device.
Primary	Metabolic Cost of Transport		5 minutes of steady state walking after two weeks of training with powered device.